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Could two existing drugs unlock sperm production in infertile men?

NCT ID NCT06706414

Disease control Sponsor: Martin Blomberg Jensen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tests whether two drugs—denosumab and letrozole—can help men with a specific type of infertility (non-obstructive azoospermia) start producing sperm. Sixteen men will take the drugs for about three months, and researchers will check for sperm in their semen or testicular tissue. The goal is to see if this combination can improve fertility, but it's a small, early trial, so results are uncertain.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Denosumab (Prolia) injection and letrozole oral tablet
What this could lead to
If it works, this could offer a new way to help some infertile men produce sperm, potentially enabling biological fatherhood.
What could go wrong
This is a very small, early-phase trial with only 16 men. It may not work for everyone, and the long-term safety and effectiveness are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Infertile men ≥ 18 years and \< 60 years of age with azoospermia with normal semen volume (\> 0.9 mL) verified by minimum 2 semen samples. * No identifiable cause of obstruction. * Testis size (Prader Orchidometer) ≤ 15 mL on both sides in patients where no prior TESE is available * Serum AMH levels ≥5 pmol/L. Exclusion Criteria: * Chronic diseases, defined as diagnosis where signs, symptoms, and treatment imply an expected long duration and lack of a cure, such as diabetes mellitus, metabolism disorders, osteoporosis, colitis, etc. * Chromosome anomalies e.g. Klinefelter Syndrome, XX male * AZFa/b/c microdeletions besides b2/b3 og gr/gr * Detected CFTR mutation * Men with current or previous malignancies, or at potential risk of testicular cancer after baseline examination and ultrasound will be excluded * Men with hypocalcemia at baseline, defined as albumin corrected calcium \< 2.17 mmol/L or total calcium \< 2.14 mmol/L * Serum vitamin D (25OHD) levels \< 25 nmol/L * estimated Glomerular Filtration Rate (eGFR) \< 60 mL/min/1,73 m2 * Insufficient dental status * Hypersensitivity to latex, Denosumab, or to any of the excipients (acetic acid, sodium hydroxide, Sorbitol (E420), Polysorbate 20) will be excluded. * Serum Inhibin B \< 5 pg/mL * Androgen replacement therapy * Hypogonadotropic hypogonadism * BMI ≥ 35 kg/m2

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Conditions

The condition(s) this trial relates to.

azoospermia male infertility

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infertility, male

Contacts and locations

Locations

  • Division of Translational Endocrinology, Department of Endocrinology and Internal Medicine, Herlev and Gentofte Hospital

    Herlev, 2730, Denmark

More trials for these conditions

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